MAUDE Adverse Event Report: DISCUS DENTAL, LLC PHILIPS ZOOM; ZOOM CHAIRSIDE KIT

Model Number	22-3764, ZM2564 AND 881055601540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sensitivity of Teeth (2427)
Date of Event	01/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discus dental received a complaint on (b)(6) 2019, in which the patient experienced severe pain after the third session of the in-office chairside teeth whitening procedure.Office called in and was advised to apply relief acp gel for 30 minutes and take ibuprofen.Office called back saying the pain did not go away and seemed to be worse.Pain and sensitivity is a common side effect of the zoom in-office chairside teeth whitening procedure.However, since the cosmetic procedure uses zoom2 advanced power lamp (class i device) and relief acp (class ii device) was used to treat sensitivity, this incident is being reported to fda.No impact on shipped products from the same lot and no similar complaint from the lot of cosmetic gel.No containment action is required.The kit and gel were used up during the procedure and were not returned.The retain sample of the teeth whitening gel, sku: 22-3764, lot: 18165002, was tested on 01/17/2019, and results were within specifications.Reviewed the device/batch history records of zoom! teeth whitening kit, sku: 881055601540, lot: 18165003 and gel, sku: 22-3764, lot: 18165002.No out of specification or discrepancy was found.Reviewed deviation and ncmr records of zoom2 advanced power lamp and no out of specification or discrepancy was found.Reviewed complaints history, no other similar incident was reported from the same lot numbers.Reviewed direction for use of the kit.The dfu describes steps for candidate qualification, warnings, ingredients, treatment for sensitivity and other precautions.No product failure or out of specifications was found in the product.Potential cause may be due to a pre-existing sensitivity.Based on the investigation results and available information, discus dental concludes there was no malfunction or failure in the product.No corrective actions are required.
Event or Problem Description
Discus dental received a complaint on (b)(6) 2019, in which the patient experienced severe pain after the third session of the in-office teeth whitening cosmetic procedure.Dental office called in and was advised to apply relief acp gel for 30 minutes and take ibuprofen.Office called back saying the pain did not go away and seemed to be worse.
Additional Manufacturer Narrative
Original report: discus dental received a complaint on 01/16/2019, in which the patient experienced severe pain after the third session of the inoffice chairside teeth whitening procedure.Office called in and was advised to apply relief acp gel for 30 minutes and take ibuprofen.Office called back saying the pain did not go away and seemed to be worse.Pain and sensitivity is a common side effect of the zoom in-office chairside teeth whitening procedure.However, since the cosmetic procedure uses zoom2 advanced power lamp (class i device) and relief acp (class ii device) was used to treat sensitivity, this incident is being reported to fda.No impact on shipped products from the same lot and no similar complaint from the lot of cosmetic gel.No containment action is required.The kit and gel were used up during the procedure and were not returned.The retain sample of the teeth whitening gel, sku: 22-3764, lot: 18165002, was tested on 01/17/2019, and results were within specifications.Reviewed the device/batch history records of zoom' teeth whitening kit, sku: 881 055601 540.Lot: 18165003 and gel, sku: 22-3764, lot: 18165002.No out of specification or discrepancy was found.Reviewed deviation and ncmr records of zoorn2 advanced power lamp and no out of specification or discrepancy was found.Reviewed complaints history, no other similar incident was reported from the same lot numbers.Reviewed direction for use of the kit.The dfu describes steps for candidate qualification.Warnings, ingredients, treatment for sensitivity and other precautions.No product failure or out of specifications was found in the product.Potential cause may be due to a pre-existing sensitivity.Based on the investigation results and available information, discus dental concludes there was no malfunction or failure in the product.No corrective actions are required.Follow up report: added udi number (b)(4) and lamp information zm2564 serial number (b)(6).
Event or Problem Description
Discus dental received a complaint on 01/16/2019, in which the patient experienced severe pain after the third session of the in-office chairside teeth whitening procedure.Office called in and was advised to apply relief acp gel for 30 minutes and take ibuprofen.Office called back saying the pain did not go away and seemed to be worse.

• Brand Name: PHILIPS ZOOM
• Common Device Name: ZOOM CHAIRSIDE KIT
• Manufacturer (Section D): DISCUS DENTAL, LLC; 1700a south baker ave.; ontario, ca CA 91761
• MDR Report Key: 8318343
• Report Number: 1000582314-2019-00001
• Device Sequence Number: 2258676
• Product Code: EEG
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/23/2019
• Device Model Number: 22-3764, ZM2564 AND 881055601540
• Device Lot Number: 18165002 & 18165003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 50 YR